🔍 RecallPedia

Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..

Class I - Dangerous
💊 Drugs Recalled: May 21, 2019 Torrent Pharma Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot #s: a) Lot #: 18D027, 18D028, 18D029; Exp. 04/2020. b) 18D029A, Exp. 04/2020; 18E001B; 18E010B, Exp. 05/2020; 18F016A; 18F017A; 18F037A, Exp. 06/2020; 18J021; 18J023; 18J023A; 18J024, Exp. 09/2020; 18K001; 18K002, Exp. 10/2020; 19A003; 19A022, Exp. 01/2021; 19B009, Exp. 02/2021.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Torrent Pharma Inc
Reason for Recall:
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..

Product Codes/Lot Numbers:

Lot #s: a) Lot #: 18D027, 18D028, 18D029; Exp. 04/2020. b) 18D029A, Exp. 04/2020; 18E001B; 18E010B, Exp. 05/2020; 18F016A; 18F017A; 18F037A, Exp. 06/2020; 18J021; 18J023; 18J023A; 18J024, Exp. 09/2020; 18K001; 18K002, Exp. 10/2020; 19A003; 19A022, Exp. 01/2021; 19B009, Exp. 02/2021.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1381-2019

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